In a health care facility, sterilization generally refers to the process of eliminating all bacteria and other living organisms from the surfaces of instruments, medical devices, implants and other articles used in sterile surgical procedures. High level disinfection generally refers to a process of eliminating most bacteria and other microorganisms, except spores, on instruments and other articles used in certain surgical procedures. A traditional thermal sterilization process uses steam under pressure. Low-temperature chemical sterilization processes use ethylene oxide, hydrogen peroxide, hydrogen peroxide/plasma, or peracetic acid in vapor form as the sterilant, as well as gamma irradiation and electron beam sterilization. In each process, the sterilizer is designed to kill all viable living organisms within a sterilization chamber. To achieve this objective, health care personnel must select the appropriate sterilization process and carefully monitor its parameters and employ adequate preparation, packaging and sterilizer loading techniques.
To verify successful sterilization, health care facilities typically use sterilization process monitors. A sterilization process monitor is a device that measures and displays information to indicate whether a sterilization cycle met the required conditions necessary to achieve sterilization. Examples of sterilization monitors include: biological indicators, chemical indicators, chemical integrators, Bowie-Dick test packs, and challenge packs. A chemical sterilization monitor, for example, responds to one or more conditions necessary for proper sterilization, such as temperature, time, and sterilant concentration or exposure. A biological monitor carries a biological agent, and indicates successful sterilization when the biological agent has been killed. The chemical monitor is typically placed within a specific device pack or within a load containing articles to be sterilized. The biological monitor is typically placed in a test package within a load containing articles to be sterilized.
Another form of monitor is a sterilizer strip, sometimes referred to as a mechanical monitor. A sterilizer strip may take the form of a graph or printout from a sterilizer that records cycle parameters like time, temperature and pressure during a sterilization cycle. Thus, the sterilization strip serves as a record of the measured conditions.
Following the sterilization process, the chemical sterilization monitor aids sterilization personnel, e.g., in a health care facility, in identifying loads that have been exposed to the conditions necessary for sterilization. The load may carry other information, often incorporated within the monitor, that identifies the load for record-keeping purposes. For example, a monitor, such as a chemical monitor or a sterilization strip, may carry text or bar code information that uniquely identifies the load.
To achieve effective sterilization workflow, record-keeping, and safety, a health care facility must devote substantial resources, personnel, training and administrative resources to the sterilization process. In particular, it is necessary to maintain accurate records of sterilization processes to enable better quality control and verify compliance with applicable standards. Regulatory agencies and independent audit organizations may require access to sterilization records for verification of regulatory compliance or accreditation. Accordingly, orderly and comprehensive record-keeping is important to a sterilization facility.